| CTRI Number |
CTRI/2024/05/067379 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate Effect of Motor Imagery versus Action Observation Technique on performance of sit to stand using kineovea software for stroke people |
|
Scientific Title of Study
|
Immediate Effect of Motor Imagery versus Action observation technique on performance of sit to stand in stroke survivors: A Crossover study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghav Jhanwar |
| Designation |
Post Graduate Resident |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12,Department of Neurophysiotherapy,Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9511700715 |
| Fax |
|
| Email |
raghavzawar1.rz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Department of Neuro physiotherapy, Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetali Paliwal |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12, Department of Neuro physiotherapy, Thube Park, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
8766996948 |
| Fax |
|
| Email |
chetalipaliwal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park , Shivaji Nagar Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raghav Jhanwar |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy 11/12 Thube Park Shivaji Nagar, Pune 411005
Pune
MAHARASHTRA |
9511700715
raghavzawar1.rz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute For Orthopaedics and Rehabilitation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, (2) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motor Imagery and Action Observation Technique |
The Experimental group will receive Motor imagery training and action observation training for 1 time with washout period of 48 hours in between two techniques |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group 45-65 years
Sub-acute to Chronic stroke patients
Ability to understand simple verbal commands (MMSE score of 25 points or higher)
Brunstrom stage 4
Persons with intact Proprioception and Kinesthetic sensation |
|
| ExclusionCriteria |
| Details |
Spinal and lower extremity deformity, Perceptual deficits like hemi-spatial neglect, attention and memory deficits. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinovea software version 0.95 |
Pre-intervention
Post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Portable Force Plate |
Pre-intervention
Post-intervention |
| Five times Sit to Stand |
Pre-intervention
Post-intervention |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
19/03/2025 |
| Date of First Enrollment (Global) |
05/06/2024 |
| Date of Study Completion (Global) |
19/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After stroke, the ability to do sit to stand independently is difficult for the individuals. Sit to stand is the basis for the transfer activities and is essential for the transition in activities like bed-to-chair and chair-to-toilet. Motor imagery training is a cognitive process in which an internal representation of a movement is activated in working memory. This is helpful in improving sit to stand activity. Due to Action observation technique the activity of mirror neuron, cortex excitability in primary motor area increases so this will be helpful for improving sit to stand activity.As there are limited literature present on Kinovea software for sit to stand activity in stroke patients, this study will help to assess the angle of knee joint and position of pelvis.so this research is to see whether of which effect of motor imagery or action observation technique the sit to stand performance is improving among stroke survivors and on portable force plate measuring plantar pressures.
|